Common use of Health Care Products Manufacturing Clause in Contracts

Health Care Products Manufacturing. The manufacture of the Company’s and its Subsidiaries’ products by or on behalf of the Company and its Subsidiaries is being conducted in compliance with all applicable Health Care Laws, including, without limitation, the FDA’s current good manufacturing practice regulations at 21 CFR Part 820, and, to the extent applicable, the respective counterparts thereof promulgated by any other Governmental Authority, except where such noncompliance would not, singly or in the aggregate, have a Material Adverse Effect. Neither the Company nor any of its Subsidiaries has had any manufacturing site (whether Company-owned, Subsidiary-owned or, to the Company’s knowledge, that of a third party manufacturer for the Company’s or its Subsidiaries’ products) subject to a Governmental Authority shutdown or import or export prohibition, nor received any unresolved written notice of adverse finding, warning letter, untitled letter, requests to make material changes to the Company’s or its Subsidiaries’ products, processes or operations, or similar written correspondence or notice from the FDA, Health Canada, or any other Governmental Authority alleging or asserting material noncompliance with any Health Care Laws or any governmental licenses required by any such Health Care Laws. To the Company’s knowledge, neither the FDA, Health Canada, nor any other Governmental Authority is considering such action.

Health Care Products Manufacturing. The manufacture of the Company’s and its Subsidiariessubsidiaries’ products by or on behalf of the Company and its Subsidiaries subsidiaries is being conducted in compliance with all applicable Health Care Laws, including, without limitation, the FDA’s current good manufacturing practice regulations at 21 CFR Part 820, and, to the extent applicable, the respective counterparts thereof promulgated by any other Governmental Authority, except where such noncompliance would not, singly or in the aggregate, have a Material Adverse Effect. Neither the Company nor any of its Subsidiaries subsidiaries has had any manufacturing site (whether Company-owned, Subsidiarysubsidiary-owned or, to the Company’s knowledge, that of a third party manufacturer for the Company’s or its Subsidiariessubsidiaries’ products) subject to a Governmental Authority shutdown or import or export prohibition, nor received any unresolved written notice of adverse finding, warning letter, untitled letter, requests to make material changes to the Company’s or its Subsidiariessubsidiaries’ products, processes or operations, or similar written correspondence or notice from the FDA, Health Canada, or any other Governmental Authority alleging or asserting material noncompliance with any Health Care Laws or any governmental licenses Governmental Licenses required by any such Health Care Laws. To the knowledge of the Company’s knowledge, neither the FDA, Health Canada, nor any other Governmental Authority is considering such action.

Health Care Products Manufacturing. The manufacture of the Company’s and its Subsidiaries’ products by or on behalf of the Company and its Subsidiaries is being conducted in compliance with all applicable Health Care Laws, including, without limitation, the FDA’s current good manufacturing practice regulations at 21 CFR Part 820, and, to the extent applicable, the respective counterparts thereof promulgated by any other Governmental Authority, except where such noncompliance would not, singly or in the aggregate, have a Material Adverse Effect. Neither the Company nor any of its Subsidiaries has had any manufacturing site (whether Company-owned, Subsidiary-owned or, to the Company’s knowledge, that of a third party manufacturer for the Company’s or its Subsidiaries’ products) subject to a Governmental Authority shutdown or import or export prohibition, nor received any unresolved written notice of adverse finding, warning letter, untitled letter, requests to make material changes to the Company’s or its Subsidiaries’ products, processes or operations, or similar written correspondence or notice from the FDA, Health Canada, or any other Governmental Authority alleging or asserting material noncompliance with any Health Care Laws or any governmental licenses required by any such Health Care Laws. To the Company’s knowledge, neither the FDA, Health Canada, nor any other Governmental Authority is considering such action.